Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp

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The purpose of this study is to see how well DFD-07 works in treating actinic keratosis on the face and scalp during 8 weeks of treatment. The study will also look at any unwanted effects of the study drug.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

To be eligible for the study, the patients have to fulfil all of the following criteria at Visit 1:

Written informed consent has been signed and dated prior to any study related procedure or initiation of a wash out period

Skin type I, II or III according to Fitzpatrick

5-8 Actinic Keratosis (AK) mild to moderate grade lesions in an approximately 25 cm2 region of scalp, forehead or face that are non-hypertrophic and non-hyperkeratotic

18 years of age or older

Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with a secondary contraceptive option should the patient become sexually active. All women of childbearing potential must have a negative urine pregnancy test (test must have a sensitivity of at least 25 IU/ML for human chorionic gonadotropin) at the Baseline Visit. A female is considered of childbearing potential unless she is pre-menarche, postmenopausal with no menses for at least 12 months or surgically sterile. Reliable methods of contraception are hormonal methods or intrauterine devices in use for at least 90 days prior to the Baseline Visit or barrier methods plus spermicide use for at least 14 days prior to the Baseline Visit or a partner who has had a vasectomy at least 3 months prior to the Baseline Visit.

≥ 60 days washout from prohibited medications:

Masoprocol

5-Fluorouracil

Cyclosporine

Retinoids

Trichloroacetic Acid/Lactic Acid Peel

50% Glycolic Acid Peel

Topical or systemic diclofenac, celecoxib or any other non-sterioda anti-inflammatory drug (however daily low-dose aspirin is allowed, as long as the patient has been on a stable dose, ≤ 100 mg once a day, for 60 days prior to the start of the study.) Note: Patients may use acetaminophen/paracetamol as needed

Photodynamic therapy

Topical or systemic immunomodulating agents including:

Systemic, topical or intralesional interferon

Imiquimod (Aldara, Zyclara)

Topical ingenol mebutate (Picato)

Topical tacrolimus

Topical pimecrolimus

Sirolimus

Cyclosporin

Intralesional Bacillus Calmette-Guerin (BCG)

Topical coal tar products

Topical or systemic corticosteroids

Exclusion Criteria:

Patients who fulfil one or more of the following criteria, will not be eligible for the study:

Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drug (NSAID) or a component of the formulation of the study medication